BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Leigh R. Hochberg, MD, PhD.
Summary
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Description
The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders * Complete or incomplete tetraplegia (quadriplegia) * Must live within a three-hour drive of the Study site * (There are additional inclusion criteria) Exclusion Criteria: * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect abil…
Interventions
- DevicePlacement of the BrainGate2 sensor(s) into the motor-related cortex
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Locations (5)
- University of California, DavisSacramento, California
- Stanford University School of MedicineStanford, California
- Emory University School of MedicineAtlanta, Georgia
- Massachusetts General HospitalBoston, Massachusetts
- Providence VA Medical CenterProvidence, Rhode Island